There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient.

FDA DeterminedCause 2

Process control

Action

Arrow International sent an Urgent Medical Device Recall Notification letter dated October 14, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any affected product,to return product complete the enclosed Recall Acknowledgement Form and fax to 1-800-343-2935, ATTN: Customer Service. Customers were asked to completed the Recall Acknowledgement Form even if they have none of the affected product.
Customers with questions were instructed to contact their local sales representative or Customer Service at 1-800-343-2935.
For questions regarding this recall call 610-378-0131.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.